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RecruitingNCT07696533ULTIMATEUpdated Jul 15, 2026

ULTIMATE Study (Carotid Ultrasound Vs CT Coronary Calcium Scoring to Reclassify Symptomatic Patients With Chronic Coronary Syndrome)

An interventional study of Carotid Ultrasound in Chronic Coronary Syndrome and Obstructive Coronary Artery Disease, sponsored by London North West Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by London North West Healthcare NHS Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

  • Chest pain is one of the most common symptoms of heart disease. This could be due to narrowing in heart's blood vessels, which needs to be investigated.
  • Currently, people with a low risk of narrowing of heart vessels usually have a CT scan of the heart first. This scan is good at identifying those who do not have significant narrowing. However, the scan has some drawbacks, such as exposure to a small amount of radiation.
  • We are exploring if ultrasound of the neck vessels might give us similar kind of information as the CT scan.
  • You will be asked to attend the hospital for one visit to have an ultrasound scan of your neck.
  • The findings of your neck vessels will be compared with the CT scan of your heart vessels to see if there is a similarity.
Read the detailed description

In the era of rising coronary artery disease burden, various investigations ranging from CTCA, SE, CMR, PET, SPECT and CA are being extensively relied upon to detect CAD and prevent CVD events. According to current guidelines, patients falling in the subgroup of low likelihood of obstructive CAD are investigated with CTCA and CAC score as the first line of investigation to rule out obstructive coronary artery disease [6,8]. Based on the CACS-CL alone, the low-risk RF-CL patients can be reclassified to identify more patients with very low risk of obstructive CAD, thereby allowing for deferral of further testing [6]. This method has demonstrated a high degree of reliability in the process of downgrading patients from the low-likelihood subgroup to the very-low-likelihood of obstructive CAD subgroup [29]. The reclassification of patients to the 'very low likelihood of obstructive CAD' subgroup is important, as it ensures that patients can be safely reassured, with no further requirement for investigations for obstructive CAD and at the same time reduces pressure on already compromised resources. In order to determine the CAC score, patients are exposed to ionising radiation. It is not only expensive but also requires advanced equipment, while carotid ultrasound offers a safer, quicker and more affordable option without radiation. With growing evidence connecting carotid plaque with CAD in both asymptomatic and symptomatic individuals, its role in risk reclassification of symptomatic patients warrants further investigation. The objective of this study is to determine the accuracy of carotid ultrasound in reclassifying a specific patient subgroup compared to CAC score. Should carotid ultrasound be able to demonstrate the desired accuracy as of CAC score in this sub-group, it would be feasible to investigate such patients without exposure to ionising radiation or iodinated contrast, while concomitantly reducing costs.

02

Conditions studied

  • Chronic Coronary Syndrome
  • Obstructive Coronary Artery Disease

Keywords

  • Carotid Ultrasound
  • Computed Tomography Coronary Calcium Scoring
  • Chronic Coronary Syndrome
  • Obstructive Coronary Disease
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 225 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

London North West Healthcare NHS Trust is the lead sponsor of 55 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 18 years old
  2. Symptomatic patients with suspected CCS, judged by the clinician to require CTCA with CAC scoring, for the diagnosis of CAD
  3. Have a RF-CL 5-15%, as calculated using ESC guidelines
  4. Able to give to participate in the study and its follow up

Exclusion criteria

Exclusion Criteria:

  1. Age \<18 years old
  2. Diagnosed ACS requiring hospitalization or urgent or emergent testing
  3. Known CAD with prior MI, PCI, CABG or any angiographic evidence of CAD (≥50% lesion in a major epicardial vessel)
  4. History of previous stroke or known peripheral vascular disease
  5. Known significant cardiac congenital abnormalities
  6. Pregnancy
  7. \< 1 years
  8. Unable to provide written
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
225 participants (estimated)

Study arms

  • Experimental
    Carotid Ultrasound

    Diagnostic Test: Carotid Ultrasound

Interventions

  • Diagnostic testCarotid Ultrasound

    Carotid ultrasound

06

What researchers measure

Primary outcomes

  1. 1. Reclassification of patients based on detection of carotid plaques defined as: a. Patients with no carotid plaques will reclassify as very low likelihood (<5%) b. Patients with 1-2 plaques as low likelihood for obstructive CAD (5-15%) c. Patients with

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07696533
Lead sponsor
London North West Healthcare NHS Trust
Responsible party
Sponsor
First posted
Jul 10, 2026
Start date
Jul 3, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Nov 30, 2032 (estimated)
Last update
Jul 15, 2026

Study contacts

Emma Howard
Contact
lnwh-tr.cardiacresearch@nhs.net
+4402088692548

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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